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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Dade Owren's Veronal Buffer - 00630414640273

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873839
In Commercial Distribution

  • 00842768019494 ()
  • 00630414640273 ()
10873839

  • Buffered sample diluent IVD

Dade Thrombin Reagent - 00630414640266

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873837
In Commercial Distribution

  • 00842768019517 ()
  • 00630414640266 ()
10873837

  • Fibrinogen assay (factor I) IVD, reagent

Dade Ci-Trol Heparin Control, Low - 00630414640259

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873833
In Commercial Distribution

  • 00842768019548 ()
  • 00630414640259 ()
10873833

  • Multiple coagulation factor IVD, control

Dade Actin FSL Activated PTT Reagent - 00630414640242

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873831
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640242 ()
10873831

  • Activated partial thromboplastin time (APTT) IVD, reagent

INNOVANCE D-Dimer Controls - 00630414640181

INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
10873855
In Commercial Distribution

  • 00630414640181 ()
10873855

  • D-dimer IVD, control

Dade Ci-Trol Coagulation Control Level 1 - 00630414640167

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873842
In Commercial Distribution

  • 00842768019470 ()
  • 00630414640167 ()
10873842

  • Multiple coagulation factor IVD, control

Dade Data-Fi Abnormal Fibrinogen Control - 00630414640150

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10873836
In Commercial Distribution

  • 00842768019524 ()
  • 00630414640150 ()
10873836

  • Fibrinogen assay (factor I) IVD, control

Dade Fibrinogen Determination Reagents - 00630414640105

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873937
In Commercial Distribution

  • 00630414640105 ()
10873937

  • Fibrinogen assay (factor I) IVD, kit, clotting

LA Control High - 00630414640099

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873936
In Commercial Distribution

  • 00842768019685 ()
  • 00630414640099 ()
10873936

  • Lupus anticoagulant marker IVD, control

LA Control Low - 00630414640013

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873935
In Commercial Distribution

  • 00842768019678 ()
  • 00630414640013 ()
10873935

  • Lupus anticoagulant marker IVD, control
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